209360Orig1s000 - Food and Drug Administration · 2018-01-30 · Since the ICH Q3A(R2) guidelines...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209360Orig1s000 PRODUCT QUALITY REVIEW(S)

Transcript of 209360Orig1s000 - Food and Drug Administration · 2018-01-30 · Since the ICH Q3A(R2) guidelines...

Page 1: 209360Orig1s000 - Food and Drug Administration · 2018-01-30 · Since the ICH Q3A(R2) guidelines for new drug substances excludes peptides from consideration, the proposed limits

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209360Orig1s000

PRODUCT QUALITY REVIEW(S)

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MohanSapru

Digitally signed by Mohan SapruDate: 12/11/2017 09:34:26AMGUID: 504f821600000ec6d20b59d2b68eb3d2

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RaoKambhampati

Digitally signed by Rao KambhampatiDate: 11/30/2017 10:51:22AMGUID: 508da72000029fd06e8c9283b7414189

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 11/30/2017 10:53:18AMGUID: 50816dbc000085595ca3284bbca465a8

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GerlieGieser

Digitally signed by Gerlie GieserDate: 11/27/2017 09:35:45AMGUID: 507592ba00003d190b2ea34fe8fb8ccb

JingLi

Digitally signed by Jing LiDate: 11/27/2017 11:37:27AMGUID: 508da7420002bb05ac913303b23c39bb

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JianliXue

Digitally signed by Jianli XueDate: 12/08/2017 08:57:12AMGUID: 584afcd70041453da94854122880ab0c

NandiniBhattacharya

Digitally signed by Nandini BhattacharyaDate: 12/08/2017 11:08:23AMGUID: 508da70c00028f454473851fced0e9d4

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MohanSapru

Digitally signed by Mohan SapruDate: 12/11/2017 10:01:49AMGUID: 504f821600000ec6d20b59d2b68eb3d2


209360Orig1s000 - Food and Drug Administration · 2018. 1. 30. · Fred Senatore MD, PhD, FACC; Tzu-Yun McDowell PhD 505(b)(2) NDA 209360 Angiotensin II CDER Clinical Review Template

209360Orig1s000 - Food and Drug Administration · 2018. 1. 30. · Fred Senatore MD, PhD, FACC; Tzu-Yun McDowell PhD 505(b)(2) NDA 209360 Angiotensin II CDER Clinical Review Template

CHEMICALS. DRUG DRUG ADDICTION DRUG DEPENDENCE.

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IMPURITIES GUIDELINE FOR RESIDUAL S Q3C(R4) · guideline for drug substance (Q3A, Impurities in New Drug Substances) or drug product (Q3B, Impurities in New Drug Products), or all

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IV IT M… ·  · 2015-08-19Q2b) Explain the addressing of 8051 microcontroller Q3a) ... QP Code : Q5a) Explain the interfacing of 8051 with 8255 PPI ... What is pulse position modulation

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Q3C (R6) Step 5 - impurities: guideline for residual solvents · 2017-12-19 · expressed in the guideline for drug substance (Q3A, Impurities in New Drug Substances) or drug product

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Methods to Assess Drug-Drug and Drug -Chemical Interactions

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Pharmaceutical APIs, impurities and primary reference ...€¦ · ICH Q3A (R1): Impurities in New Drug Substances ICH Q3B (R2): Impurities in New Drug Products ICH Q3C (R5): Impurities:

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Drug Scene Drug Use and Drug-Related Health Consequences ...

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209360Orig1s000 - EMCrit Blog...NDA. Thus, all 3 non-CMC review disciplines believe that this application could be approved as a 505(b)(1) application. Accordingly, the sponsor has

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Dangerous Liaisons: Drug-drug, drug-nutrient interactions...Dangerous Liaisons: Drug-drug, drug-nutrient interactions Disclosure • No real or potential conflict of interest to disclose.

Dangerous Liaisons: Drug-drug, drug-nutrient interactions...Dangerous Liaisons: Drug-drug, drug-nutrient interactions Disclosure • No real or potential conflict of interest to disclose.

Genotoxic impurities in small molecule drug candidates · 2010-05-06 · ICH Impurities Guidance Documents • ICH Q3A(R2) and ICH Q3B(R2) • Impurities in New Drug Substances/Products

Genotoxic impurities in small molecule drug candidates · 2010-05-06 · ICH Impurities Guidance Documents • ICH Q3A(R2) and ICH Q3B(R2) • Impurities in New Drug Substances/Products

Impurities - Jan · PDF file3 Possible classification of impurities Legal basics ICH Q3A/ICH Q3B ICH Q3C Specific limits for residues of metal catalysts Limits of genotoxic impurities

Impurities - Jan · PDF file3 Possible classification of impurities Legal basics ICH Q3A/ICH Q3B ICH Q3C Specific limits for residues of metal catalysts Limits of genotoxic impurities

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Drug/Drug and Drug/Food Interactions with Target-Specific ...excellence.acforum.org/sites/default/files/Vazquez_AC Forum NOAC... · Drug/Drug and Drug/Food Interactions with Target-Specific

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209360Orig1s000 - Food and Drug Administration · 2018-01-30 · resuscitation and vasopressors; it may have synergistic effect on improving mean arterial pressure (MAP) and have

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AMultidisciplinaryInvestigationtoDeterminetheStructureand ...Q3A(R2), the International Conference on Harmonization (ICH) guidance for controlling impurities in new drug substance

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